Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Leyden Delta BV, Neerbosscheweg 620, 6544 LL, Nijmegen, The Netherlands
Zaponex 12.5 mg orodispersible tablets.
Zaponex 25 mg orodispersible tablets.
Zaponex 50 mg orodispersible tablets.
Zaponex 100 mg orodispersible tablets.
Zaponex 200 mg orodispersible tablets.
| Pharmaceutical Form |
|---|
|
Orodispersible tablet. Zaponex 12.5 mg orodispersible tablets: Yellow, round, flat orodispersible tablets of approximately 6.5 mm of diameter. The tablets are debossed with “C7PN” on one side and “12.5” on the other. Zaponex 25 mg orodispersible tablets: Yellow, round, orodispersible flat tablets of approximately 8 mm of diameter. The tablets are debossed with “C7PN” on one side and “25” on the other. Zaponex 50 mg orodispersible tablets: Yellow, round, flat orodispersible tablets of approximately 10 mm of diameter. The tablets are debossed with “C7PN” on one side and “50” on the other. Zaponex 100 mg orodispersible tablets: Yellow, round, flat orodispersible tablets of approximately 13 mm of diameter. The tablets are debossed with “C7PN” on one side and “100” on the other. Zaponex 200 mg orodispersible tablets: Yellow, round, flat orodispersible tablets of approximately 16 mm of diameter. The tablets are debossed with “C7PN” on one side and “200” on the other. |
Each orodispersible tablet contains 12.5 mg clozapine.
Excipient(s) with known effect:
Each orodispersible tablet contains 1.6 mg aspartame (E951).
Each orodispersible tablet contains 25 mg clozapine.
Excipient(s) with known effect:
Each orodispersible tablet contains 3.1 mg aspartame (E951).
Each orodispersible tablet contains 50 mg clozapine.
Excipient(s) with known effect:
Each orodispersible tablet contains 6.2 mg aspartame (E951).
Each orodispersible tablet contains 100 mg clozapine.
Excipient(s) with known effect:
Each orodispersible tablet contains 12.4 mg aspartame (E951).
Each orodispersible tablet contains 200 mg clozapine.
Excipient(s) with known effect:
Each orodispersible tablet contains 24.8 mg aspartame (E951).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Clozapine |
Clozapine has been shown to be an antipsychotic agent that is different from classic antipsychotics. Clozapine has potent anti-alpha-adrenergic, anticholinergic, antihistaminic, and arousal-reaction-inhibiting effects. It has also been shown to possess antiserotoninergic properties. |
| List of Excipients |
|---|
|
Mannitol (E421) |
Zaponex 12.5 mg orodispersible tablets are available in either:
PVC/PVDC/Al blisters containing 7, 10, 14, 20, 28, 30, 40, 50, 56, 60, 84, 90, 98, 100, 250, 300 or 500 tablets.
PVC/PVDC/Al perforated unit-dose blisters containing 7, 10, 14, 20, 28, 30, 40, 50, 56, 60, 84, 90, 98, 100, 250, 300 or 500 tablets.
HDPE bottles with or without cotton filler with a child-resistant twist-off PP closure for hospital use containing 250 or 500 tablets.
Zaponex 25 mg orodispersible tablets are available in either:
PVC/PVDC/Al blisters containing 7, 10, 14, 20, 28, 30, 40, 50, 56, 60, 84, 90, 98, 100, 250, 300 or 500 tablets.
PVC/PVDC/Al perforated unit-dose blisters containing 7, 10, 14, 20, 28, 30, 40, 50, 56, 60, 84, 90, 98, 100, 250, 300 or 500 tablets.
HDPE bottles with or without cotton filler with a child-resistant twist-off PP closure for hospital use containing 250 or 500 tablets.
Zaponex 50 mg orodispersible tablets are available in either:
PVC/PVDC/Al blisters containing 7, 10, 14, 20, 28, 30, 40, 50, 56, 60, 84, 90, 98, 100, 250, 300 or 500 tablets.
PVC/PVDC/Al perforated unit-dose blisters containing 7, 10, 14, 20, 28, 30, 40, 50, 56, 60, 84, 90, 98, 100, 250, 300 or 500 tablets.
HDPE bottles with or without cotton filler with a child-resistant twist-off PP closure for hospital use containing 250 or 500 tablets.
Zaponex 100 mg orodispersible tablets are available in either:
PVC/PVDC/Al blisters containing 7, 10, 14, 20, 28, 30, 40, 50, 56, 60, 84, 90, 98, 100, 250, 300 or 500 tablets.
PVC/PVDC/Al perforated unit-dose blisters containing 7, 10, 14, 20, 28, 30, 40, 50, 56, 60, 84, 90, 98, 100, 250, 300 or 500 tablets.
HDPE bottles with or without cotton filler with a child-resistant twist-off PP closure for hospital use containing 250 or 500 tablets.
Zaponex 200 mg orodispersible tablets are available in either:
PVC/PVDC/Al blisters containing 7, 10, 14, 20, 28, 30, 40, 50, 56, 60, 84, 90, 98, 100, 250, 300 or 500 tablets.
PVC/PVDC/Al perforated unit-dose blisters containing 7, 10, 14, 20, 28, 30, 40, 50, 56, 60, 84, 90, 98, 100, 250, 300 or 500 tablets.
HDPE bottles with or without cotton filler with a child-resistant twist-off PP closure for hospital use containing 250 or 275 tablets.
Not all pack sizes may be marketed.
Leyden Delta BV, Neerbosscheweg 620, 6544 LL, Nijmegen, The Netherlands
Zaponex 12.5 mg orodispersable tablets: PL 32553/0004
Zaponex 25 mg orodispersable tablets: PL 32553/0005
Zaponex 50 mg orodispersable tablets: PL 32553/0006
Zaponex 100 mg orodispersable tablets: PL 32553/0007
Zaponex 200 mg orodispersable tablets: PL 32553/0008
29/03/2019
| Drug | Countries | |
|---|---|---|
| ZAPONEX | Netherlands, United Kingdom |
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